French Public Health Code
In forceI.-The Agence nationale de sécurité du médicament et des produits de santé shall fulfil its obligations in terms of pharmacovigilance and participation in European Union activities in this field.
The National Agency for the Safety of Medicines and Health Products carries out its pharmacovigilance missions under the conditions defined in Article R. 5311-2 in order to carry out a scientific assessment of all information, to examine options for preventing or reducing risks and, if necessary, to take appropriate measures. It defines pharmacovigilance guidelines, leads and coordinates the actions of the various parties involved, ensures compliance with surveillance procedures and participates in the European Union's activities in this field.
Pharmacovigilance activities are periodically evaluated. The results of this evaluation are sent to the European Commission every two years from the date of the first transmission.
II - The Agency receives the following documents:
1° Notifications, transmitted electronically via the European "Eudravigilance" database, of adverse reactions occurring in France, reported in this database by companies and organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150 ;
2° Reports sent by companies and organisations exploiting medicinal products or products mentioned in article R. 5121-150 in application of II of article R. 5121-168 and article R. 5121-170 ;
3° Information transmitted by the regional pharmacovigilance centres mentioned in Article R. 1413-61-4;
4° Reports sent in application of article R. 5121-175 by pharmaceutical establishments, including the pharmaceutical establishments of public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their activity of carrying out hospital preparations and magistral preparations;
5° Reports sent in application of Article R. 5121-176 by the pharmacies for internal use mentioned in Article L. 5126-1 for their activity in producing or subcontracting hospital preparations and compounding;
6° Reports sent pursuant to Article R. 5121-174 by the holder of the authorisation provided for in Article L. 4211-6.
The Agency receives reports of duplication sent by companies and organisations exploiting medicinal products or products mentioned in article R. 5121-150, in application of article R. 5121-167.
It shall inform the European Medicines Agency and the company or organisation exploiting a product mentioned in article R. 5121-150 of any duplication it has detected in the notification of adverse reactions.
III - The Agency assesses the periodic safety update reports it has received in accordance with Article R. 5121-170 and sends its assessment reports to the Committee for Pharmacovigilance Risk Assessment mentioned in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.
In collaboration with the European Medicines Agency, the Agency shall monitor the results of the risk reduction measures provided for in the risk management plans, the results of the obligations referred to in Articles R. 5121-36-1, R. 5121-37-3 and R. 5121-43, assesses the updates to the risk management system and monitors the information recorded in the European "Eudravigilance" database in order to determine whether new risks have emerged, whether existing risks have changed and, if so, whether they have an impact on the risk-benefit balance of the medicinal product.
It informs the European Medicines Agency and the company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 when new risks, changes in existing risks or changes in the risk-benefit balance relating to the medicinal product are identified in application of the previous paragraph.
It shall inform the European Medicines Agency, the European Commission and the Member States of the European Union or the States party to the Agreement on the European Economic Area of any such communication, at the latest twenty-four hours before the dissemination to the general public of a notice concerning information relating to pharmacovigilance, except in an emergency. Any information of a personal nature or of a commercially confidential nature shall be deleted, unless the disclosure of such information is necessary for the protection of public health.
When the notice referred to in the previous paragraph concerns medicinal products or products containing the same active substance or the same combination of active substances and which are authorised in several Member States of the European Union or States party to the Agreement on the European Economic Area, the National Agency for the Safety of Medicinal Products and Health Products shall draw up, in collaboration with the other Member States of the European Union or States party to the Agreement on the European Economic Area, a joint message relating to the safety of the medicinal product or product concerned. The Agency disseminates this notice to the general public in accordance with the timetable laid down by the European Medicines Agency. Any information of a personal nature or of a commercially confidential nature is deleted, unless disclosure of such information is necessary for the protection of public health.
